A Phase IV, Multi-center, Randomized, Partially Double Blinded, Placebo Controlled Study, to Evaluate the Safety of Daily Inhaled Zanamivir 10 mg Versus Placebo and Daily Oral Oseltamivir 75 mg Versus Placebo for Influenza Prophylaxis in Healthy Volunteers for 16 Weeks (SEA 004)

NCT00980109 Phase 4 COMPLETED

This is a multicenter, randomised, four arms placebo controlled study to evaluate the safety and tolerability of 10 mg inhaled zanamivir once a day and 75 mg oseltamivir capsule orally once a day relative to placebo over 16 weeks (112 days). Enrolled subjects will be randomly assigned to 2:1:2:1 ratio (active oseltamivir: placebo: active zanamivir: placebo) on one of the four study treatment groups. It is hypothesized that oseltamivir and zanamivir will protect participants from becoming infected with influenza.

Details

Lead sponsor	University of Oxford
Phase	Phase 4
Status	COMPLETED
Enrolment	390
Start date	2009-09
Completion	2010-09

Conditions

• Influenza

Interventions

• active oseltamivir
• placebo capsule
• zanamivir for inhalation
• placebo for inhalation

Primary outcomes

• Proportion of subjects who withdraw from the study because of serious adverse events (SAEs) that are possibly or probably or definitely related to the study drug — 1 year

Countries

Thailand